Europe – Economic Operators: Roles and Obligations Under EU’s MDR

Regulatory and legal experts share their views on the European Union’s revised Medical Device Regulation (MDR) and the EU’s requirements for Economic Operators (EOs) to play major roles in medical device authorizations and postauthorization monitoring. The article also highlights roles and responsibilities for Manufacturers, Authorized Representatives, Importers and Distributors (MAID) for assuring compliance with new EU MDR in addition to public health/patient safety goals. The article was developed in cooperation with Ludger Möller and Erik Vollebregt who will be presenting this topic at RAPS Euro Convergence, 11-13 May 2020 in Brussels, Belgium.
The EU Medical Devices Regulation (MDR)1 and In Vitro Diagnostic Medical Devices Regulation (IVDR)2 introduce a complete economic operator regime for medical devices. After being approved by the European Council and the European Parliament, in May 2017, the European Medical Devices Regulation (MDR) came into force. MDR implementation is set for May 2020.3 While the new regulations aim at enhancing medical device safety and effectiveness, their genesis is the result of several years of new developments, both scientific and technical, in addition to the perceived need to redesign the EU regulatory landscape to improve quality and safety and alignment of medical devices regulation with EU goods regulation for other CE marked goods set out in the 2008 template New Legislative Framework for the Marketing of Products (see recitals 25-27 MDR). Since 2008, the EU has gradually implemented the economic operator requirements in every CE marking directive and regulation that was renewed. Through MDR, new roles and responsibilities have appeared up and down the medical device supply line with the requirement that Manufacturers, Authorized Representatives, Importers and Distributors (MAID) function as Economic Operators (EOs) with distinct and sometimes overlapping roles and responsibilities. In short, under the EO mandate, quality and regulatory compliance responsibilities have risen to new heights and are much broader than with the older regulations…